While Mr. Watson did answer Alexander Graham Bell’s first telephone call, what we’re talking about here is IBM’s Watson. The Mayo Clinic recently released results from a study whereby Watson “in the 11 months after implementation, there was on average an 80% increase in enrollment to Mayo’s systemic therapy clinical trials for breast cancer.” That’s a huge increase given that ~3-5% of cancer patients participate in clinical trials. There’s also a Mayo Clinic radio (yes, there is such a thing) podcast for your listening enjoyment. For those in the clinical development industry, this could be a substantial step in using technology to increase clinical trial participation rates. DYK that IBM’s Watson is named after their first CEO, industrialist Thomas J. Watson? You do now and you’re now less likely to lose on Jeopardy.
We recently read one of the better reports on the use of digital technologies in the world of clinical development. Why is it better? Because Deloitte provides some actual case studies/ use cases for these technologies. In one example, a service provider, Science 37, used telemedicine to conduct a complete virtual Phase II study. We have no idea whether the trial will be part of an FDA submission, but cool nonetheless. Another interesting idea from Deloitte is using “Synthetic trial arms or master protocols to reduce the number of patients required to test investigational treatments. A synthetic trial arm uses data from previously completed trials or real-world evidence and is particularly useful in rare disease trials or when a placebo approach is not appropriate or ethical, as is often the case in oncology.” Love it. Speaking of synthetic, here’s a list of the worst synthetic fabrics to wear.
Want some help with your 2018 weight loss resolution? 23andMe might be able to help. In December they announced the “Weight Loss Intervention Study” noting it will attempt to uncover more about why each of us responds differently to exercise and diet. If you’re a 23andMe customer, then maybe you can be 1 of 100,000 people they intend to recruit. This is not 23andMe’s first time conducting clinical trials. They have conducted them in Lupus and Parkinson’s. According to Dr. Liana Del Gobbo, “We’d like to better understand the genetic, demographic, psychosocial, and behavioral characteristics that predict weight loss success overall, and on different lifestyle interventions.” Cool, because anything’s better than this method of weight loss. And 23andMe is probably not done after raising $250M in September, just like InsightCity.
Last week, researchers found that exercise can counteract the cognitive decline some patients experience post-breast cancer treatment. It’s the 457th publication since 2012 to use a Fitbit device in research. Or to put it a different way, this study found that 83 percent of clinical trials used a Fitbit as opposed to another brand. Researchers apparently just really prefer it. That’s good news for the company, since it now has a slew of clinical data under its belt, and it’s thinking about a run at a medical device designation a few years in the future. According to their GM of Health Solutions, “as we start going deeper down the health road with more and more advanced sensors, I’d say, just stay tuned.” Oooooh, mysterious.
In the age of Amazon Prime, grocery delivery, and, yep, even sock delivery subscriptions, it’s getting easier and easier to never leave the house. And it’s even more annoying when you do have to venture out and interact with other human beings, amirite? Luckily for us hermits, PAREXEL and Sanofi aim to make it easier to participate in clinical trials from the comfort of your Lazy Boy. The two companies are launching a pilot study to test the medical and scientific viability of wearable devices in clinical trials using PAREXEL’s patient sensor solution. The goals are to make things easier on patients and sites, collect a whole bunch of data, and reduce costs all the way around. High five for progress!
Fresh off the clock, ex-FDA commish Robert Califf recently vented a few concerns he has with speeding up drug approvals. #1: Faster approval does nothing to address popular concern for the cost of drugs. Pharma will still say they must recoup hefty development costs and people will still not trust that explanation. #2: Are speed and safety at odds? As Califf puts it, “Declaring a drug safe after very little information is treacherous.” All drugs have risk and this risk is only uncovered through evidence. Check out 22 case studies where the bottom fell out between Phase II and III. And #3: Drugs can’t be approved faster if the FDA needs more FDA-ites – employees. We’re not sure what they call themselves.